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IRCT20180218038783N5 IRCT 2023-09-03 Babol University of Medical Sciences Investigating the ٍEffect of Educational Intervention based on the Ottawa Nutritional guide on Nausea and Vomiting in Pregnant women Investigating the effect of Educational Intervention based on the Ottawa Nutritional guide on Nausea and Vomiting in Pregnant women 2023-11-01 anticipated 60 Complete https://irct.ir/trial/72341 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Pregnant women will be included in the study if they are eligible based on the entry criteria and after obtaining written informed consent. Due to the fact that the subjects of the study do not enter the study at the same time, and the researchers cannot predict in advance which group each person who enters the study will belong to. To assigning the target group to one of the two study groups; The intervention group and the control group (two groups A and B) will use the Block Randomization method with ten blocks. Then the participants will be assigned to one of two groups 1 with a ratio of 1:1 according to the block randomization protocol (produced by Random Allocation Software), so that the researcher cannot predict which group the next person will be in. intervention will be placed. Randomization list based on software output: Allocation concealment In order to hide the random assignment, the codes created by the software will be placed in the envelope so that it is not clear which group the next person will be assigned to. Concealment of random allocation refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before the allocation of the individual. Without hiding the random sequence, there is a possibility of revealing the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary for people who have the criteria to enter the research, a decision to accept or reject participation in the study should be made first and the informed consent form should be completed and then the participants will be assigned to each of the groups. Different methods can be used to hide random allocation. In this study, the method of opaque sealed envelopes with random sequence will be used. Based on the sample size of this research, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed, Blinding description: In this study, considering that after randomization, the pregnant women themselves and the interventionist cannot be blinded (because the type of intervention is known). Completing questionnaires is also self-reported. Therefore, blinding cannot be done in the first stage. Blinding will only be done for the data analyst. N/A Nausea and vomiting of pregnancy. Intervention 1: Intervention group: After people are placed in two intervention and control groups, two days a week will be determined for pregnant women in the intervention group, one day before the training session, pregnant women will be reminded through a phone call. Educational program during two 60-minute sessions in groups of two to five people, Ottawa nutrition guide training (general guidelines; nutritional recommendations; other recommendations on lifestyle and acupressure) with lecture methods, question and answer and group discussion, lecture with slide show will provide. The educational content will include: the first session, general Ottawa guidelines for nausea and vomiting and the second session, other points will include lifestyle changes, complementary medicine, acupressure (practical finger acupressure training). After the end of the second session, the content will be provided to the intervention group in the form of a booklet for studying at home. During the first two weeks from the start of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete, and the intervention group will also be given the Ottawa recommendations checklist to complete every night before going to bed. During these two weeks, telephone calls will be made to the intervention group twice a week with an interval of three days to answer their possible questions and to emphasize on doing the things taught. Then, for another two weeks, the intervention and control groups will be given the Rhodes questionnaire and the intervention group will be given the Ottawa educational guide implementation checklist to complete. Pregnant women should complete the Rhodes questionnaire based on their conditions three days before handing it over to the researcher. If someone from the intervention group does not complete the checklist, they will be excluded from the study. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. Routine pregnancy care will be provided in both groups, and if a member of the intervention and control groups experiences severe nausea and vomiting during pregnancy or is exposed to dehydration and possible complications, they will be referred to medical centers for necessary measures. Intervention 2: Control group: During the first two weeks from the beginning of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete. Then, for another two weeks, the Rhodes questionnaire will be completed again for the intervention and control groups. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. During the study period, routine pregnancy care will be performed in the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr.Fereshteh Behmanesh
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 47745-471676 +98 11 3219 9592 f.behmanesh@mubabol.ac.ir Babol University of Medical Sciences scientific Dr.Fereshteh Behmanesh
Ganj Afrooz Street, University Square, Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 47745-471676 +98 11 3219 9592 f.behmanesh@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) The gestational age should be 4-16 weeks (4 full weeks to 15 weeks and 7 days). Singleton pregnancy. Mother's age should be 15-45 years. Be literate in reading and writing. Not suffering from a known physical or mental illness. Do not use drugs to reduce nausea and vomiting except vitamin B6. Score 3-16 in response to the Rhodes questionnaire. Body mass index is equal to or less than 30. Do not have hearing, speech or mental retardation. Do not smoke, use drugs or alcohol. 15 years 45 years Female Obstetrical problems may occur during the study. Vomiting that has a cause other than pregnancy. Being hospitalized due to severe nausea and vomiting of pregnancy. R11 Nausea and vomiting Other Other Intervention group: After people are placed in two intervention and control groups, two days a week will be determined for pregnant women in the intervention group, one day before the training session, pregnant women will be reminded through a phone call. Educational program during two 60-minute sessions in groups of two to five people, Ottawa nutrition guide training (general guidelines; nutritional recommendations; other recommendations on lifestyle and acupressure) with lecture methods, question and answer and group discussion, lecture with slide show will provide. The educational content will include: the first session, general Ottawa guidelines for nausea and vomiting and the second session, other points will include lifestyle changes, complementary medicine, acupressure (practical finger acupressure training). After the end of the second session, the content will be provided to the intervention group in the form of a booklet for studying at home. During the first two weeks from the start of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete, and the intervention group will also be given the Ottawa recommendations checklist to complete every night before going to bed. During these two weeks, telephone calls will be made to the intervention group twice a week with an interval of three days to answer their possible questions and to emphasize on doing the things taught. Then, for another two weeks, the intervention and control groups will be given the Rhodes questionnaire and the intervention group will be given the Ottawa educational guide implementation checklist to complete. Pregnant women should complete the Rhodes questionnaire based on their conditions three days before handing it over to the researcher. If someone from the intervention group does not complete the checklist, they will be excluded from the study. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. Routine pregnancy care will be provided in both groups, and if a member of the intervention and control groups experiences severe nausea and vomiting during pregnancy or is exposed to dehydration and possible complications, they will be referred to medical centers for necessary measures. Control group: During the first two weeks from the beginning of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete. Then, for another two weeks, the Rhodes questionnaire will be completed again for the intervention and control groups. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. During the study period, routine pregnancy care will be performed in the control group. Average total score of nausea, vomiting and belching in pregnant women. Timepoint: During the first two weeks from the beginning of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete, and the intervention group will also be given a checklist for carrying out the Ottawa recommendations. Then, for another two weeks, the intervention and control groups will be given the Rhodes questionnaire and the intervention group will be given the Ottawa educational guide implementation checklist to complete. Pregnant women should complete the Rhodes questionnaire based on their conditions three days before handing it over to the researcher. Method of measurement: Rhodes Nausea and Vomiting Index. Average sexual satisfaction score. Timepoint: Before the beginning and after the fourth week of the intervention. Method of measurement: Hudson sexual satisfaction questionnaire. Babol University of Medical Sciences Approved 2023-08-28 Ethics Committee of Health Research Institute Ganj Afrooz Street, University Square, Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)